U.S. EPA, Toxic Substances Control Act Inventory Representation for Products Containing Two or More Substances: Formulated and Statutory Mixtures (1995) (ELR Order No. AD-3997)

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 263-267

TSCA Inventory Representation for Products Containing Two or More Substances Page 263

Toxic Substances Control Act

Inventory Representation for Products

Containing Two or More Substances:

Formulated and Statutory Mixtures

I. Introduction

his paper explains t he conventions that are applied to

listings of cer tain mixtures for the Chemica l Substance

Inventory that is mainta ined by the U.S. Environmen-

tal Protection Agenc y (EPA) under the Toxic Sub-

stances Control Act ( TSCA). is paper discusses the

Inventory representation of mixtu res of substances that

do not react together (i.e., formulated mixt ures) as well

as those combinations th at are formed during certain

manufactur ing activities and are designated as m ix-

tures by the Agenc y (i.e., statutory mix tures). Complex

reaction products are covered in a s eparate paper. e

Agency’s goal in developing t his paper is to make it

easier for the users of the Inventory to inter pret Inven-

tory listings a nd to understand how new mixtures

would be identied for Inventory inclusion.

Fundamental to the Inventory a s a whole is the prin-

ciple that entries on the Inventory are identie d as

precisely as possible for the commercia l chemical sub-

stance, as repor ted by the submitter. Substances that

are chemically i ndisting uishable, or even identical, may

be listed dierently on t he Inventory, depending on the

degree of knowledge th at the submitters possess and

report about such substance s, as well as how submit-

ters intend to represent the chemical identities to t he

Agency and to cus tomers. Although t hese chemically

indistingu ishable substances are named di erently on

the Inventory, this is not a “nomenclature” issue, but

an issue of substance re presentation. Submitters should

be aware that their c hoice for substance representat ion

plays an important role in t he Agency’s determinat ion

of how the substance wil l be listed on the Inventory.

II. Def‌inition of Terms

TSCA identies t wo type s of materials: (1) chemical

substances and (2) mix tures of chemical substances.

e Inventory lists only chemica l substances. It does

not list mixture s; however, the individual c omponents

of mixtures a re listed separately.

“Chemical substanc e” is dened in section 3 of TSCA

(and in section 710 of the Agency’s implementing reg-

ulations) by chemical composition, by source or origi n

and by identication of certa in categories of materials

that are not considered “chemical subs tances”:

“Chemical substanc e” means any organic or

inorganic substa nce of a particu lar molecular

identity, including —

(i) any combination of such subst ances occurring in

whole or in part as a result of a chem ical reac tion

or occurring in nat ure, ... .

“Chemical substanc e” does not include:

(i) any mix ture [710.2(q)], ...

“Mixture” is de ned in section 710.2(q) as:

any combination of two or more chemical s ub-

stances if the c ombination does not occur i n

nature and is not, in whole or in par t, the result

of a chemical react ion; except that “mixt ure”

does include:

(1) A ny combination which occurs, in whole or

in part, as a res ult of a chemical reaction if the

combination could have been manuf actured

for commercial purpose s without a chemical

reaction at the time the chem ical substances

comprising the combination were combined

and if, after the ee ctive date of premanufacture

notication requirements, none of the chemic al

substances comprisin g the combination is a new

chemical substa nce, and

(2) Hydrate s of a chemical substance or hydrated

ions formed by association of a chemica l sub-

stance with water.

III. Inventory Representations with

Illustrative Examples

A. Mixtures resulting from blending

substances that do not react.

A blend of two or more substances that h as been physi-

cally combined without a chemic al reaction is consid-

ered to be a mixture. Suc h a blend, as a whole entity,

is excluded from the Inventory and prema nufacture

notication (PMN) requirements for ne w chemical

substances. Ind ividual components of such a mixture

are separately report able for the Inventory, however,

and are considered to be “new substanc es” if they are

not currently listed on the Inventory.

NOTICE: e policies set out in this doc ument are

not nal Agency a ction, but are intended solely as

guidance. ey a re not intended, nor can they be relied

upon, to create any rights enforceable by a ny party i n

litigation with the United States. E PA ocials may

decide to follow the guidanc e provided in this doc u-

ment, or to act at variance with t his guidance, based

on an analysis of spe cic circumstances.